Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
170 participants
INTERVENTIONAL
2020-01-22
2025-09-01
Brief Summary
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Detailed Description
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The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.
Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control
classic analgetic protocol
No interventions assigned to this group
intervention
intranasal Sufentanil
Sufentanil
intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses
Interventions
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Sufentanil
intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* \<18 years
* prisoners
* lesions of head, face or abdomen
* no consent given or possible
* pain not scorable
* known drug abuse or substitution therapy
* chronic level 3 pain medication
* intake of level 3 \< 8 hours
* intoxicated patient
* allergy or intolerance to opiates
* renal or hepatic insufficiency
* \< 50kg body weight
* hemodynamic instability
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Saint Pierre
OTHER
Responsible Party
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Locations
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CHU Saint Pierre
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Malinverni S, Kreps B, Lucaccioni T, Bouazza FZ, Bartiaux M, Plumacker A, Pascu A, Youatou Towo P. Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial. Emerg Med J. 2024 Jan 22;41(2):83-88. doi: 10.1136/emermed-2023-213353.
Other Identifiers
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SUFIN002
Identifier Type: -
Identifier Source: org_study_id
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